Protocol summary

Study aim
Comparison of the Effect of 8 Week of Massage and Stretching Exercises on Pain, Range of Motion and Functional Disability of the Neck and Shoulders due to Myofascial Trigger Points of the Trapezius Muscle
Design
30 Patients Were Randomly Assigned to a Massage Group, a Stretching Group and a Control Group. Patients in both Experimental Groups Received Exercise for 8 Weeks and 3 Sessions per Week. Variables were Evaluated Before and After 8 Weeks of Intervention. Pain, Range of Motion and Functional Disability were Assessed Using Visual Analog Scale, Goniometer and Neck Pain and Disability Index, Respectively.
Settings and conduct
The Present Study was a Semi-experimental Study with a Pre-test and Post-test Design with Two Experimental Groups and a Control Group. 30 Patients Were Randomly Assigned to a Massage Group, a Stretching Group and a Control Group. Patients in both Experimental Groups Received Exercise for 8 Weeks and 3 Sessions per Week. Variables were Evaluated Before and After 8 Weeks of Intervention. Pain, Range of Motion and Functional Disability were Assessed Using Visual Analog Scale, Goniometer and Neck Pain and Disability Index, Respectively.
Participants/Inclusion and exclusion criteria
Myofascial Trigger Points of the Trapezius Muscle
Intervention groups
Massage and Stretching Exercises
Main outcome variables
Pain, Range of Motion and Functional Disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046035N3
Registration date: 2020-07-11, 1399/04/21
Registration timing: prospective

Last update: 2020-07-11, 1399/04/21
Update count: 0
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Hossein Shahrokhi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2756
Email address
h.shahrokhi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of 8 Week of Massage and Stretching Exercises on Pain, Range of Motion and Functional Disability of the Neck and Shoulders due to Myofascial Trigger Points of the Trapezius Muscle
Public title
The Effect of Massage and Stretching Exercises on Pain, Range of Motion and Functional Disability of the Neck and Shoulders due to Myofascial Trigger Points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one Trigger Point in the Trapezius Muscle Having Pain and Limitations in the Range of Motion of the Neck and Shoulders Muscle Pain without Neurological Symptoms The Gender is Male
Exclusion criteria:
Age
From 44 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The simple Randomization Method was used to Assign Individuals to two Groups that in this Method, Random Allocation Software was used to Create a Random Sequence. Then, for not Clearing that People Assigning to which Group before Allocated in other Words Allocation Concealment, was used as a Central Randomization Method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.SSRC.REC.1399.023

Health conditions studied

1

Description of health condition studied
Myofascial Trigger Points of Trapezius Muscle
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
At the Beginning of the Study (Before the Start of the Intervention) and After 8 Weeks of Intervention
Method of measurement
VAS Scale

2

Description
Range of Motion
Timepoint
At the Beginning of the Study (Before the Start of the Intervention) and After 8 Weeks of Intervention
Method of measurement
Goniometer

3

Description
Functional Disability
Timepoint
At the Beginning of the Study (Before the Start of the Intervention) and After 8 Weeks of Intervention
Method of measurement
Neck Pain and Disability Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Stretching Exercises for 8 Weeks, 3 Sessions per Week, 1 Hour per Session
Category
Rehabilitation

2

Description
Intervention Group: Stretching Exercises for 8 Weeks, 3 Sessions per Week, 1 Hour per Session
Category
Rehabilitation

3

Description
Control Group: Without any Training and just doing normal Daily Activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Physiotherapy
Full name of responsible person
Fateme Novrouzi Lajimi
Street address
Mehr Building, Eftekhari Alley, Tehran Street
City
Qaemshahr
Province
Mazandaran
Postal code
3766768677
Phone
+98 11 4466 7654
Email
kazem.hajian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raja University
Full name of responsible person
Hadi Miri
Street address
Novrizian, Motahhari Blvd
City
Qazvin
Province
Qazvin
Postal code
95834-34148
Phone
+98 28 3367 7101
Email
hd.miri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raja University
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Tohid Shahr, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Tohid Shahr, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Tohid Shahr, Sabzevar, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All Potential Data Can be Shared After People have not been Identified
When the data will become available and for how long
Start the Access Period one Year After Printing the Results
To whom data/document is available
Data will be Available to Academic and Scientific Researchers
Under which criteria data/document could be used
Any Kind of Functional Analysis on the Submitted Data is Allowed
From where data/document is obtainable
By Email: h.shahrokhi@hsu.ac.ir
What processes are involved for a request to access data/document
By Email: h.shahrokhi@hsu.ac.ir and the Reason for Using the Documents
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